BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24445443 · Received February 25, 2026

    Report

    Report Number
    1220648-2026-04022
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED BASED ON ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE COULD NOT BE DETERMINED AS THE PRODUCT WASN'T RETURNED FOR INVESTIGATION. THE CAUSE OF THE PRIMING PROBLEM COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT WHEN THE STAFF DISCOVERED THE PROBLEM, THEY CHANGED THE ORIGINAL PURGE CASSETTE THINKING THAT COULD BE THE SOLUTION, BUT THE ISSUE SEEMS TO BE MORE WITH THE PURGE SIDE ARM.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING SUPPORT, AN IMPELLA 5.5 EXPERIENCED AN ¿AIR IN PURGE¿ ALARM AFTER THE PATIENT RETURNED FROM THE DENTAL CLINIC AND THE DEVICE WAS RECONNECTED IN THE INTENSIVE CARE UNIT. THE NURSE PERFORMED THE STANDARD PURGE DE-AIRING STEPS TWICE WITHOUT RESOLUTION; THE ALARM CLEARED AFTER THE THIRD ATTEMPT. FOLLOWING ALARM RESOLUTION, STAFF OBSERVED WHAT APPEARED TO BE PURGE FLUID LEAKING WITHIN THE PURGE ARM RESERVOIR AREA AND EXTERNALLY AT THE CONNECTION POINT BETWEEN THE WHITE IMPELLA CATHETER AND THE PURGE ARM ON THE PATIENT SIDE. DESPITE THE OBSERVED LEAKAGE, PURGE FLOW AND PURGE PRESSURES REMAINED WITHIN NORMAL LIMITS, AND ALL OTHER IMPELLA PARAMETERS WERE WITHIN EXPECTED RANGES. THE CLINICAL TEAM WAS ADVISED TO CONTINUE HOURLY MONITORING. NO SIGNS OR SYMPTOMS OF PATIENT INJURY WERE REPORTED, THERE WAS NO REPORTED HARM ASSOCIATED WITH THE EVENT. AT THE TIME OF WRITING THIS REPORT, THE PATIENT CONTINUES TO BE SUPPORTED BY IMPELLA 5.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509635 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026815772 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male